OBJECTIVE To investigate the characteristics of adverse drug events(ADEs) associated with off-label use of tamsulosin in female patients and to identify potential risk signals based on data from the US FDA Adverse Event Reporting System(FAERS), thereby providing a reference for its safety evaluation.

METHODS All ADE reports of tamsulosin in female patients were extracted from the FAERS database from the fourth quarter of 2003 to the third quarter of 2024. Disproportionality analyses were conducted using the Reporting Odds Ratio(ROR) and the Proportional Reporting Ratio(PRR) for signal detection. ADEs were standardized using Preferred Terms(PTs) and were categorized into System Organ Classes(SOCs) according to the Medical Dictionary for Regulatory Activities(MedDRA).

RESULTS  A total of 511 cases ADE reports from female patients were included, and 74 positive signals involving 19 SOCs were identified. The top 6 SOCs by report count were psychiatric disorders, nervous system disorders, injuries, poisonings, and procedural complications, eye disorders, various investigations, renal and urinary disorders. The top 5 PTs by frequency were off-label use, dizziness, hypotension, exposure during pregnancy, and product use for unapproved indications. The top 5 PTs by signal strength were residual urine volume increased, central nervous system stimulation, erythrocytopenia, psychogenic fatigue syndrome, and iris disorders.

CONCLUSION  This study systematically characterizes the ADE profile of tamsulosin in female patients, providing critical insights for the safety of its off-label use in women. Clinicians should carefully assess the risks when prescribing, with enhanced monitoring particularly required for special populations such as pregnant women.